A qualitative investigation of the Montgomery-Åsberg depression rating scale: discrepancies in rater perceptions and data trends in remote assessments of rapid-acting antidepressants in treatment resistant depression.

Introduction: Despite the development of many successful pharmaceutical interventions, a significant subset of patients experience treatment-resistant depression (TRD). Ketamine and its derivatives constitute a novel therapeutic approach to treat TRD; however, standard tools, such as the Montgomery-Åsberg Depression Rating Scale (MADRS) are still being used to measure symptoms and track changes. Methods: The aim of this study was to review item-level differences between rate of data change (MADRS score) and rater-weighted perception of the most useful items for assessing change in symptoms while remotely conducting the 10-item version of the MADRS in TRD in a clinical trial of rapid-acting antidepressants. Two studies of rapid-acting antidepressants in the treatment of TRD were used to identify item-scoring trends when MADRS is administered remotely and repeatedly (733 subjects across 10 visits). Scoring trends were evaluated in tandem to a rater survey completed by 75 raters. This was completed to gain insight on MADRS items' perceived level of helpfulness when assessing change of symptoms in rapid-acting antidepressant trials. Results: MADRS items 'Reduced sleep', 'Apparent sadness', and 'Pessimistic thoughts' were found to have the greatest average data change by visit, while raters ranked 'Reported sadness', 'Lassitude' and 'Apparent sadness' as the most helpful items when assessing symptom change. Discussion: The diversion between rate of data-change ranking and rater perception of helpfulness could be related to difficulty in assessing specific items, to the novel treatment itself, and/or to the sensitivity to symptom change to which raters are accustomed in traditional antidepressant treatments.

Functioning and Cognition in Patients with Schizophrenia After Initiating Treatment with Aripiprazole Lauroxil: Secondary Outcomes and Post Hoc Analysis.

Background: Clinical practice guidelines support efforts to improve functioning in patients with schizophrenia. Discrepancies in the perception of cognitive status between clinicians, patients with schizophrenia, and their caregivers have been associated with impaired functional abilities in patients; medication side effects might worsen both cognition and daily functioning. We assessed daily/social functioning and cognition in stable patients with schizophrenia who switched to the long-acting injectable (LAI) antipsychotic aripiprazole lauroxil (AL). Methods: Clinically stable adults with residual symptoms of schizophrenia or intolerance following three or more doses of paliperidone palmitate or risperidone LAI were switched to flexibly dosed open-label AL treatment (441mg, 662mg, or 882mg every 4 weeks or 882mg every 6 weeks) for six months (ClinicalTrials.gov identifier: NCT02634320). Daily/social functioning was assessed using the Personal and Social Performance Scale (PSP); total and subscale scores were summarized using descriptive statistics. The cognitive status of patients was assessed using the New York Assessment of Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) at baseline and Month 6 or early termination, providing patient, caregiver, and clinician perspectives. A post hoc analysis assessed level of agreement in ratings of cognitive status among respondents, evaluated at baseline and last assessment, using weighted kappa coefficients (0.01-0.20, slight agreement; 0.21-0.40, fair agreement; 0.41-0.60, moderate agreement; 0.61-0.80, substantial agreement.). Results: All 51 enrolled patients received one or more AL doses; 35 completed the study, and 45 contributed data at last assessment. Mean age was 40.6 years; 72.5 percent of patients were male. Based on PSP total score, functioning was maintained from baseline (mean [standard deviation (SD)]: 55.1 [10.5]) through six months of AL treatment (mean [SD]: 57.7 [13.2]). Proportions of patients rating personal and social functioning issues as "not present" or "mild" remained stable between baseline and Month 6 for each PSP subscale. At baseline (n=50), cognitive difficulties were most commonly rated "not present" or "mild" in all NY-AACENT domains by patients (58-86% across domains), clinicians (62-94%), and caregivers (50-92%), and these rates were maintained or increased at last assessment for all reporters. Weighted kappa coefficients indicated fair-to-substantial agreement between patients and clinicians across domains at last assessment (0.32-0.64; baseline: 0.14-0.55); patient-caregiver agreement ranged from 0.07 to 0.50 at last assessment (baseline: 0.25-0.60). Conclusion: In clinically stable patients with schizophrenia who initiated AL, self-reported functioning was maintained over six months of treatment. Clinician-, caregiver-, and patient-reported cognitive function was stable at baseline and maintained in all NY-AACENT domains; patient-clinician agreement on level of cognitive impairment increased over six months of treatment with AL.

Are informants required to obtain valid ratings on the Positive and Negative Syndrome Scale (PANSS)?

Ratings on the Positive and Negative Syndrome Scale (PANSS) are ideally based on both a patient interview and an informant questionnaire. In research and clinical settings, however, the informant questionnaire is often omitted. This study investigated the consequences of omitting informant information by comparing PANSS ratings of patients with schizophrenia (n = 49 patients, 77 ratings) conducted with and without informant information, respectively. Additionally, changes in symptom severity over time based on ratings with and without informant information were also compared for the full PANSS and the six-item version of the PANSS (PANSS-6). PANSS ratings including informant information were higher than those without, both at the total score and individual item level. Additionally, the full PANSS appeared less "responsive" to baseline-to-endpoint changes for ratings without informant information compared to ratings including informant information, while no differences were found for the PANSS-6.

Clinical Outcome Assessment Instruments in Schizophrenia: A Scoping Literature Review with a Focus on the Potential of Patient-reported Outcomes.

Objective: The complexity inherent in the treatment of schizophrenia results in a multitude of outcome assessments being employed when conducting clinical trials. Subjective outcome assessments and minimal clinically important differences (MCIDs) to evaluate clinical meaningfulness have gained traction; however, the extent of application in evaluation of treatments for schizophrenia is unknown. A scoping review was conducted to assess the availability of published psychometric evaluations, including MCIDs, for clinical outcome assessments used to evaluate treatments for schizophrenia. Method of Research: Key databases (PubMed®, Embase®, APA PsycINFO®, International Society for Pharmacoeconomics and Outcomes Research) were searched for studies on schizophrenia published from 2010 to 2020. Secondary sources (ClinicalTrials.gov, PROLABELS™, FDA.gov) were also reviewed. Clinical outcome assessments were organized by type (patient-reported outcomes [PROs], clinician-reported outcomes [ClinROs], observer-reported outcomes [ObsROs]) and further classified by intended use (generic, mental health, schizophrenia). Reliability and internal consistency were evaluated using Cronbach's α. External validity was evaluated by intraclass correlation coefficient (ICC). Results: Across 140 studies, 66 clinical outcome assessments were identified. MCIDs were reported for eight of the 66 studies. Of these, two were PROs (generic) and six were ClinROs/ObsROs (three mental health-specific, three schizophrenia-specific). Reliability was good across generic, mental health-specific, and schizophrenia-specific categories, whereas external validity was strong mainly for schizophrenia-specific PROs. Overall, ClinROs/ObsROs that focused on mental health had good reliability and strong external validity. Conclusion: This review provides a comprehensive overview of the clinical outcome assessments used in schizophrenia research during the past ten years. Results highlight the heterogeneity of existing outcomes and a growing interest in PROs for schizophrenia.

Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants.

The novel mechanisms of action (MOA) derived from some recently introduced molecular targets have led to regulatory approvals for rapid acting antidepressants (RAADs) that can generate responses within hours or days, rather than weeks or months. These novel targets include the N-methyl-D-glutamate receptor antagonist ketamine, along with its enantiomers and various derivatives, and the allosteric modulators of gamma-aminobutyric acid (GABA) receptors. There has also been a strong resurgence in interest in psychedelic compounds that impact a range of receptor sites including D1, 5-HT7, KOR, 5-HT5A, Sigma-1, NMDA, and BDNF. The RAADs developed from these novel targets have enabled successful treatment for difficult to treat depressed individuals and has generated a new wave of innovation in research and treatment. Despite the advances in the neurobiology and clinical treatment of mood disorders, we are still using rating instruments that were created decades ago for drugs from a different era (e.g., The Hamilton and Montgomery-Åsberg depression rating scales, HDRS, and MADRS) continue to be used. These rating instruments were designed to assess mood symptoms over a 7-day time frame. Consequently, the use of these rating instruments often requires modifications to address items that cannot be assessed in short time frames, such as the sleep and appetite items. This review describes the adaptative approaches that have been made with the existing scales to meet this need and examines additional domains such as daily activities, side effects, suicidal ideation and behavior, and role functioning. Recommendations for future studies are described, including the challenges related to implementation of these adapted measures and approaches to mitigation.

Design of a real-world, prospective, longitudinal, observational study to compare vortioxetine with other standard of care antidepressant treatments in patients with major depressive disorder: a PatientsLikeMe survey.

BACKGROUND: Major depressive disorder (MDD) is a recurrent psychiatric condition that presents challenges in responding to treatment and achieving long-term remission. To improve outcomes, a shared decision-making treatment approach with patient and healthcare practitioner (HCP) engagement is vital. PatientsLikeMe (PLM), a peer community of patients, provides information on MDD, symptoms, and treatment through forums and resources, helping patients stay engaged in their treatment journey. Data on PLM can be harnessed to gain insights into patient perspectives on MDD symptom management, medication switches, and treatment goals and measures. METHODS: This ongoing, decentralized, longitudinal, observational, prospective study is being conducted using the PLM platform in two parts, enrolling up to 500 patients with MDD in the United States aged ≥ 18 years to compare vortioxetine with other monotherapy antidepressants. The first qualitative component consists of a webinar and discussion forum with PLM community members with MDD, followed by a pilot for functionality testing to improve the study flow and questions in the quantitative survey. The quantitative component follows on the PLM platform, utilizing patient-reported assessments, over a 24-week period. Three surveys will be conducted at baseline and weeks 12 and 24 to collect data on patient global impression of improvement, depression severity, cognitive function, quality of life (QoL) and well-being, medication satisfaction, emotional blunting, symptoms of anhedonia and resilience, as well as goal attainment. Quantitative results will be compared between groups. The qualitative component is complete; patient recruitment is underway for the quantitative component, with results expected in late 2023. DISCUSSION: These results will help HCPs understand patient perspectives on the effectiveness of vortioxetine versus other monotherapy antidepressants in alleviating symptoms of MDD and improvements in QoL. Data from the PLM platform will support a patient goal-based treatment approach, as results can be shared by patients with their HCPs, providing them with insights on patient-centric goals, treatment management and adherence, as well as allowing them to observe changes in patient-related outcomes scores. Findings from the study will also help to optimize the PLM platform to build scalable solutions and connectivity within the community to better serve patients with MDD.

Validation of ratings on the six-item Positive and Negative Syndrome Scale obtained via the Simplified Negative and Positive Symptoms Interview among outpatients with schizophrenia.

BACKGROUND: The six-item Positive and Negative Syndrome Scale (PANSS-6) is a measure of the severity of core symptoms of schizophrenia, which can be administered via the brief Simplified Negative and Positive Symptoms Interview (SNAPSI). A recent study has confirmed the validity of PANSS-6 ratings as derived by SNAPSI (PANSS-6SNAPSI) among inpatients with schizophrenia. AIMS: We aimed to test the validity of PANSS-6SNAPSI among outpatients with schizophrenia using PANSS-6 ratings extracted from the 30-item PANSS-30 as derived by the Structured Clinical Interview for the Positive and Negative Syndrome Scale (PANSS-6SCI-PANSS) as a gold standard reference. METHODS: PANSS-6SNAPSI and PANSS-6SCI-PANSS ratings were obtained at two time points by independent raters with established inter-rater reliability. Agreement between PANSS-6SNAPSI and PANSS-6SCI-PANSS ratings was estimated via intra-class coefficients (ICCs) and responsiveness over time was quantified using Spearman's rank correlation coefficients. Post hoc "leave-one-out" analyses were carried out, in which each rater in turn was excluded from the ICC calculations. RESULTS: Seventy-three outpatients with schizophrenia participated in the study (mean age: 38.3 years; 56% males). The ICC for PANSS-6SNAPSI versus PANSS-6SCI-PANSS was 0.67 [95%CI = 0.56-0.76] and the Spearman's rank correlation coefficient for responsiveness was 0.40 (p = 0.004). When data from a specific outlying rater were excluded, the ICC for PANSS-6SNAPSI versus PANSS-6SCI-PANSS was 0.75 [95% CI = 0.63-0.83] and the Spearman's rank correlation coefficient for responsiveness was 0.55 (p = 0.018). CONCLUSIONS: We found PANSS-6SNAPSI ratings to have acceptable clinical validity, suggesting that PANSS-6SNAPSI can be used for both inpatients and outpatients with schizophrenia.

Clinical validation of ratings on the six-item Positive and Negative Syndrome Scale obtained via the Simplified Negative and Positive Symptoms Interview.

BACKGROUND: The six-item version of the Positive and Negative Syndrome Scale (PANSS-6) has shown promise as a brief measure of the severity of core symptoms of schizophrenia. However, since all prior analyses of the PANSS-6 were based on data extracted from studies using the full 30-item PANSS (PANSS-30), it remains unknown whether it is possible to obtain valid information for the PANSS-6 ratings via a brief interview, such as the Simplified Negative and Positive Symptoms Interview (SNAPSI). AIMS: We aimed to validate the PANSS-6 ratings obtained via the SNAPSI using the PANSS-6 scores extracted from the PANSS-30 ratings obtained via the comprehensive Structured Clinical Interview for PANSS (SCI-PANSS) as the gold-standard reference. METHODS: The PANSS-6 ratings based on the SNAPSI and the PANSS-30 ratings based on the SCI-PANSS were conducted by independent raters with established inter-rater reliability. RESULTS: Seventy-seven inpatients with schizophrenia (Mage = 35.1 ± 11.7 years; males = 57%; paranoid schizophrenia = 75%) participated in the study. The intraclass correlation coefficient (ICC) of the PANSS-6 total scores obtained using the SNAPSI and the PANSS-30-derived PANSS-6 total scores via the SCI-PANSS was 0.77 (p < 0.001). The ICC for the PANSS-6 total score and the PANSS-30-derived PANSS-8 (Andreasen's remission criteria) was 0.75 (p < 0.001). Spearman's rank correlation coefficient for changes in PANSS-6 total scores via the SNAPSI and changes in PANSS-30-derived PANSS-6 total scores was 0.70 (p < 0.001). CONCLUSIONS: Using the SNAPSI to rate the PANSS-6 enables a focused and brief assessment of the severity of core symptoms of schizophrenia, which facilitates measurement-based care and clinical decision making in the treatment of schizophrenia.

Clinical validation of the Symptom Self-rating Scale for Schizophrenia (4S) among inpatients.

PURPOSE: Self-reports of psychosis-related symptoms may be a valuable supplement to clinician-ratings, but more validation studies are required. The aim of this study was to conduct clinical validation for the Symptom Self-rating Scale for Schizophrenia (4S) in an inpatient setting. MATERIALS AND METHODS: Inpatients diagnosed with schizophrenia were invited to participate in the study. The participants completed the 4S, the 5-item World Health Organization Wellbeing Index (WHO-5) and the Sheehan Disability Scale (SDS) at two time points. Trained raters assessed participants using the 6-item Positive And Negative Syndrome Scale (PANSS-6). The relationship between the 4S and PANSS-6, self-reported side effects, functioning and wellbeing was assessed using Spearman's correlation coefficient (rho). RESULTS: Sixty-one participants completed the 4S at least once (yielding a total of 91 completed 4S questionnaires). The 4S total score was weakly correlated with the PANSS-6 total score (rho = 0.37, p < 0.001). The rho's for individual 4S and PANSS-6 subscales and item comparisons ranged from -0.24 (thought disorder) to 0.69 (hallucinations). Finally, the 4S hallucination subscale was also sensitive to change. The 4S was strongly inversely correlated with wellbeing (WHO-5) and moderately inversely correlated with functioning (SDS total score). CONCLUSION: The 4S holds promise as a valid self-report of core schizophrenia symptoms among inpatients. While the hallucination subscale seems superior to existing scales, the thought disorder subscale needs to be re-developed.

Standardized training in the rating of the six-item Positive And Negative Syndrome Scale (PANSS-6).

The six-item Positive And Negative Syndrome Scale (PANSS-6) allows for a brief assessment of the severity of core symptoms of schizophrenia. However, implementing the PANSS-6 in clinical practice requires that staff members' ratings are accurate and reliable. We aimed to investigate whether such accuracy and reliability can be obtained via a brief video-based training program. One-hundred-and-four staff members from a psychiatric hospital in Denmark participated in the training. Participants performed a baseline PANSS-6 rating based on a video of a patient being interviewed using the Simplified positive And Negative Symptoms interview (SNAPSI). Subsequently, a theoretical introduction video was displayed followed by five successive videotaped SNAPSI patient interviews. After each SNAPSI video, individual ratings were conducted before a video providing the gold standard rating was displayed. The accuracy of ratings was estimated by calculating the proportion of participants not deviating from the gold standard rating with >2 points on individual items or >6 points on the PANSS-6 total score. Reliability was tested after each step in the training by means of Gwet's Agreement Coefficient (Gwet). By the end of the training, 72% of the participants rated within the acceptable deviations of the gold standard, ranging from 60% (nurses) to 91% (medical doctors & psychologists). The reliability improved (Gwet baseline vs. endpoint) for all PANSS-6 items, except for Blunted affect. In conclusion, the majority of the staff members conducted accurate PANSS-6 ratings after a brief standardized training program, supporting the implementation of PANSS-6 in clinical settings to facilitate measurement-based care.

Consistency checks to improve measurement with the Personal and Social Performance Scale (PSP).

International Society for CNS Clinical Trials and Methodology convened an expert Working Group that assembled consistency/inconsistency flags for the Personal and Social Performance Scale (PSP). One hundred and forty seven flags were identified, 16 flag errors in deriving the PSP decile (i.e., total) score from the four individual domain scores, 74 flag inconsistencies between domain scores relative to Positive and Negative Symptom Scale (PANSS) item ratings and 57 flag inconsistencies between PSP decile score and PANSS items ratings. The flags were applied to assessments from randomized clinical trial data of antipsychotics in schizophrenia from almost 18,000 ratings. Twenty-two flags were raised in at least 5 of 1000 ratings. Nearly 20% of the PSP ratings had at least one inconsistency flag raised. Application of flags to clinical ratings may improve the reliability of ratings and validity of trials.

The brief negative symptom scale in translation: A review of psychometric properties and beyond.

Negative symptoms are a core feature of schizophrenia and associated with social and occupational impairment. To encourage treatment development and address the limitations of existing rating instruments in this area across culture, the Brief Negative Symptoms Scale (BNSS) was developed. The authors reviewed studies published since the BNSS was published in 2010 that examined the psychometric properties of the instrument in translation and compared for consistency, psychometric performance and related features. Eleven published cross-cultural validation studies demonstrated the translated versions of the BNSS have strong psychometric properties, similar to the original English version. The internal consistency ranged from 0.88 to 0.98 and the inter-rater reliability ranged from 0.81 to 0.98 for the total score. The BNSS exhibited good convergent validity with existing measures of similar constructs and function, and good discriminant validity relative to other constructs. Recent research also reported that the BNSS is sensitive to drug effects, with effect sizes comparable to established scales. The results of confirmatory factor analyses revealed that the 5-factor structure of negative symptoms in schizophrenia (blunted affect, anhedonia, avolition, asociality, and alogia) crosses cultures. This psychometric evidence suggests that the BNSS is a valid and reliable instrument for assessing pathological mechanism underlying the negative symptoms of schizophrenia across cultures and can be a useful instrument in global clinical trials.

Network Analysis Indicates That Avolition Is the Most Central Domain for the Successful Treatment of Negative Symptoms: Evidence From the Roluperidone Randomized Clinical Trial.

A recent conceptual development in schizophrenia is to view its manifestations as interactive networks rather than individual symptoms. Negative symptoms, which are associated with poor functional outcome and reduced rates of recovery, represent a critical need in schizophrenia therapeutics. MIN101 (roluperidone), a compound in development, demonstrated efficacy in the treatment of negative symptoms in schizophrenia. However, it is unclear how the drug achieved its effect from a network perspective. The current study evaluated the efficacy of roluperidone from a network perspective. In this randomized clinical trial, participants with schizophrenia and moderate to severe negative symptoms were randomly assigned to roluperidone 32 mg (n = 78), 64 mg (n = 83), or placebo (N = 83). Macroscopic network properties were evaluated to determine whether roluperidone altered the overall density of the interconnections among symptoms. Microscopic properties were evaluated to examine which individual symptoms were most influential (ie, interconnected) on other symptoms in the network and are responsible for successful treatment effects. Participants receiving roluperidone did not differ from those randomized to placebo on macroscopic properties. However, microscopic properties (degree and closeness centrality) indicated that avolition was highly central in patients receiving placebo and that roluperidone reduced this level of centrality. These findings suggest that decoupling the influence of motivational processes from other negative symptom domains is essential for producing global improvements. The search for pathophysiological mechanisms and targeted treatment development should be focused on avolition, with the expectation of improvement in the entire constellation of negative symptoms if avolition is effectively treated.

Clinical Validation of the Autism Behavior Inventory: Caregiver-Rated Assessment of Core and Associated Symptoms of Autism Spectrum Disorder.

There is a need for measures to track symptom change in autism spectrum disorder (ASD). We conducted a validation study on a revised version of the Autism Behavior Inventory (ABI), and a short form (ABI-S). Caregivers of individuals (6-54 years) with confirmed diagnoses of ASD (N = 144) completed the ABI and other rating scales at 4 time points. Scale consistency for each domain, 3-5 day test-retest reliability, and construct validity, determined by comparison to pre-specified scales, were all good. Change in the ABI was congruent with changes in other instruments. Collectively, results suggest incipient suitability of the ABI as a measure of changes in core and associated symptoms of ASD.Trial Registration NCT02299700.

High glycemic index and glycemic load diets as risk factors for insomnia: analyses from the Women's Health Initiative.

BACKGROUND: Previous studies have shown mixed results on the association between carbohydrate intake and insomnia. However, any influence that refined carbohydrates have on risk of insomnia is likely commensurate with their relative contribution to the overall diet, so studies are needed that measure overall dietary glycemic index (GI), glycemic load, and intakes of specific types of carbohydrates. OBJECTIVE: We hypothesized that higher GI and glycemic load would be associated with greater odds of insomnia prevalence and incidence. METHODS: This was a prospective cohort study with postmenopausal women who participated in the Women's Health Initiative Observational Study, investigating the relations of GI, glycemic load, other carbohydrate measures (added sugars, starch, total carbohydrate), dietary fiber, and specific carbohydrate-containing foods (whole grains, nonwhole/refined grains, nonjuice fruits, vegetables, dairy products) with odds of insomnia at baseline (between 1994 and 1998; n = 77,860) and after 3 y of follow-up (between 1997 and 2001; n = 53,069). RESULTS: In cross-sectional and longitudinal analyses, higher dietary GI was associated with increasing odds of prevalent (fifth compared with first quintile OR: 1.11; CI: 1.05, 1.16; P-trend = 0.0014) and incident (fifth compared with first quintile OR: 1.16; CI: 1.08, 1.25; P-trend < 0.0001) insomnia in fully adjusted models. Higher intakes of dietary added sugars, starch, and nonwhole/refined grains were each associated with higher odds of incident insomnia. By contrast, higher nonjuice fruit and vegetable intakes were significantly associated with lower odds of incident insomnia. Also, higher intakes of dietary fiber, whole grains, nonjuice fruit, and vegetables were significantly associated with lower odds of prevalent insomnia. CONCLUSIONS: The results suggest that high-GI diets could be a risk factor for insomnia in postmenopausal women. Substitution of high-GI foods with minimally processed, whole, fiber-rich carbohydrates should be evaluated as potential treatments of, and primary preventive measures for, insomnia in postmenopausal women.

Adapting the Goal Attainment Approach for Major Depressive Disorder.

The need for patient-centered care has become a focal point of healthcare improvement initiatives. Shared decision making-in which patients and clinicians communicate about various treatment options and goals and patient input is considered when making treatment decisions-has been associated with improved health and quality of life. A method of treatment evaluation allowing incorporation of patient-specific goals and perspectives is of increasing interest to healthcare providers, payers, and patients. An approach that allows incorporation of shared goal setting is possible via use of an instrument called the Goal Attainment Scale (GAS). This scale provides the structure for measuring progress toward treatment goals set through patient-clinician collaboration. The goal attainment approach has been used as a primary outcomes measure in numerous studies but not in major depressive disorder (MDD). As MDD is a complex, multidimensional disorder affecting each patient differently, the use of GAS methodology is a relevant framework for setting personalized meaningful treatment goals. Initial research into the feasibility of using the GAS in MDD (GAS-D) to measure patient-centric outcomes that may be neglected when more traditional scales are used has been encouraging. The objective of this Commentary is to provide background and rationale for implementation of the GAS-D in clinical practice.Funding Takeda Pharmaceutical Company, Ltd., and Lundbeck LLC.

Patient attitudes toward and goals for MDD treatment: a survey study.

Background/Objectives: Major depressive disorder (MDD) is a highly prevalent disorder, frequently diagnosed and treated in a primary care setting; however, little information is available about the treatment decision-making process between MDD patients and their providers. A shared decision-making and goal attainment approach to establishing and tracking progress toward treatment goals that are meaningful to individual patients is explored in this survey study. In addition, information about patient perspectives on setting treatment goals, medication selection/switching, and engaging patients with their health care professionals was also collected and evaluated. Methods: A 50-question online survey was administered to members of the PatientsLikeMe community who indicated an MDD diagnosis and a switch in antidepressant medications within the past 2 years. Follow-up interviews were also conducted with a small subset of these participants. Results: Of the 200 participants who completed the survey, 42% reported currently having goals for MDD treatment. These goals were typically in the areas of physical health (62.7%), cognitive functioning (60.2%), and social aspects of life (57.8%). A majority of survey participants (61%) believed the goal attainment approach would be helpful to set and evaluate treatment goals. Conclusions: The data provide important insights into patient perspectives on the development of formal treatment plans and goals for MDD. In addition, the data also support the use of a patient-centric approach to shared decision-making by using a goal attainment scale to establish and track progress toward treatment goals that are meaningful to MDD patients in real-world clinical practice. The results of this study can be used to inform best practices in patient-clinician communication when developing an MDD treatment plan and goals.